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临床试验/NCT06027775
NCT06027775已完成不适用

Chemotherapy Alone Versus Chemotherapy Plus Targeted Therapy as Adjuvant Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: A Retrospective Cohort Study

Fudan University0 个研究点目标入组 198 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
198
主要终点
relapse-free survival

研究概览

简要总结

Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with a tolerable toxicity profile.

详细描述

This multi-center study enrolled consecutive patients with initially unresectable CRLM who underwent conversion therapy or radiofrequency ablation (RFA) and achieved no NED status between June 1, 2013, and June 30, 2020, from Zhongshan Hospital of Shanghai, Zhongshan Hospital of Xiamen, Cancer Hospital of Beijing. The inclusion criteria were as follows: (1) with histologically confirmed CRC; (2) with initially unresectable synchronous liver metastases (LMs); (3) accepted conversion therapy and successfully converted into resectable status; (4) underwent R0 intestinal and hepatic resection; (5) accepted adjuvant therapy. The exclusion criteria were as follows: (1) R1/R2 resection; (2) extrahepatic metastases; (3) accepted postoperative monotherapy; (4) lack of follow-up data. According to the adjuvant therapy regimen (with or without targeted therapy), the cohorts were divided into CA cohort and CT cohort. The study was approved by the ethics committee of three medical centers and was adhered to Good Clinical Practice guidelines and the Declaration of Helsinki. Written informed consent was obtained from all participants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 and ≤ 75 years;
  • Histologically confirmed CRC;
  • Initially unresectable synchronous liver metastases (LMs);
  • Accepted conversion therapy and successfully converted into resectable status;
  • Underwent R0 intestinal and hepatic resection;
  • Accepted adjuvant therapy.

排除标准

  • R1/R2 resection;
  • Extrahepatic metastases;
  • Accepted postoperative monotherapy;
  • Lack of follow-up data.

研究组 & 干预措施

Chemotherapy plus Targeted therapy (CT)

The treatment decisions and evaluation of treatment outcomes, such as the assessment of metastases resectability and tumor response, were carried out by the multi-disciplinary team (MDT) comprising experts from each medical centers. In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy plus targeted therapy, as adjuvant therapy.

干预措施: Targeted agent (Drug)

结局指标

主要结局

relapse-free survival

时间窗: 3 years

The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death

次要结局

  • overall survival(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xu jianmin

Head of Colorectal Surgery

Fudan University

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